Job Description

Job Title: Plant Head - Medical Device Manufacturing

Location:

India

Job Type:

Full-Time

Experience:

minimum 5+ years in Medical Device Manufacturing

About the Role

We are seeking an experienced

Plant Head

to lead and oversee complete manufacturing operations for our medical device production facility. The ideal candidate will have strong expertise in

ISO 13485

,

EU MDR

,

MDSAP

, and a proven track record of managing production, quality, regulatory, and cross-functional teams within a medical device environment.

Key Responsibilities

Provide strategic leadership for all plant operations, including

production, quality, maintenance, supply chain, and EHS

. Ensure full compliance with

ISO 13485

,

EU MDR

,

MDSAP

, and applicable Indian and international regulatory requirements. Drive continuous improvement initiatives across manufacturing processes to meet quality, cost, and delivery targets. Lead audits (internal and external) and ensure timely closure of CAPA, NCs, and audit observations. Oversee planning, budgeting, resource allocation, and performance management for plant operations. Establish and maintain robust documentation systems in line with regulatory and QMS requirements. Collaborate with R&D, QA/RA, and global teams for new product transfers, validations (IQ/OQ/PQ), and scale-up activities. Ensure workplace safety, regulatory compliance, and adherence to best manufacturing practices. Foster a high-performance culture focused on accountability, quality, and operational excellence.

Required Qualifications

Minimum 5 years

of experience in manufacturing operations, with strong exposure to

medical devices

. Experience manufacturing with Silicone, Plastic, Metal parts of medical device. Hands-on experience with

ISO 13485 QMS

,

EU MDR compliance

,

MDSAP requirements

, and regulatory audits. Strong knowledge of sterilization processes, cleanroom operations, validations, and device assembly processes (preferred). Excellent communication, leadership, and problem-solving skills.

Preferred Skills

Lean Manufacturing, Six Sigma, or operational excellence certifications. Ability to scale manufacturing and manage high-growth operations.

What We Offer

Competitive salary and performance-based incentives Opportunity to lead a key manufacturing site with high strategic importance Growth opportunities in a rapidly expanding medical device organization Supportive work environment with advanced manufacturing infrastructure
Job Types: Full-time, Permanent

Pay: ₹332,962.72 - ₹661,741.30 per year